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| Name | Class |
|---|---|
| Genome British Columbia | INDUSTRY |
| Genome Alberta | OTHER |
| University of Calgary | OTHER |
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Heart muscle disorders are a common cause of heart failure: a life-threatening condition that can cause dangerous abnormal heart rhythms (arrhythmia) and a buildup of fluid in the body (edema). In British Columbia (BC) and Alberta, patients with heart failure are cared for in specialized Heart Function Clinics (HFC). Providers in these clinics rapidly diagnose and treat heart failure because early treatment prevents death and disability. In some situations, particularly in young people, heart failure is caused by abnormalities in the genetic blueprint of the heart muscle - this is present at birth and passed down within families (i.e. hereditary). The investigators can diagnose this genetic abnormality by a simple blood or saliva test, which allows for better treatment of patients and diagnosis of family members to protect against heart failure and death. In BC and Alberta, people suspected of having this form of heart failure must be referred to highly specialized programs to receive genetic testing, as these healthcare systems currently do not offer genetic testing through HFCs. However, HFC providers are unaware or discouraged to refer patients because of very long waitlists of these programs. In this study, the investigators want to educate, enable, and empower HFC cardiologists to order genetic testing for heart failure. If such an intervention demonstrates success in this study, patients will no longer have to wait for up to 3 years to see a genetic specialist. Patients will be diagnosed and treated earlier, and their family members who might be in danger of having the condition can be informed more quickly. The investigators aim to leverage this study to encourage healthcare leadership to facilitate more timely access to genetic testing by showing the positive impact on health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mainstreamed Genetic Testing through Heart Function Clinics | Experimental | Mainstreamed genetic testing offered directly by the Heart Function Clinic cardiologist with video-based genetic counselling tools |
|
| Traditional Referral Pathway for Genetic Testing | No Intervention | Traditional referral pathway to a specialized cardiac genetics clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health service delivery change | Other | Genetic testing for patients with unexplained non-ischemic cardiomyopathy offered directly by cardiologists in Heart Function Clinics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of genetic testing for non-ischemic cardiomyopathy (NICM) | Proportion of eligible patients who complete clinical genetic testing for non-ischemic cardiomyopathy (NICM) following referral from a Heart Function Clinic. | Through 12 months after first participant enrollment |
| Time to genotypic diagnosis | Time (in days) from the date informed consent for genetic testing is signed to the date genetic test results are returned. | Up to 12 months after consent for genetic testing is provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a change in clinical management following genetic test results | Change in clinical management is defined as the initiation, discontinuation, or modification of at least one of the following, documented in the medical record after return of genetic test results:
|
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Inclusion Criteria:
Alberta sites - Left ventricular ejection fraction of less than 50% and any degree of left or right ventricular dilation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Roston, MD/PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Centre Cardiac Function Clinic | Calgary | Alberta | T1Y6J4 | Canada | ||
| Foothills Medical Centre Cardiac Function Clinic |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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Cluster randomized crossover trial with 4 sites (each province will have an intervention and control site; allocations will remain in place for the first 4 months - after 4 months, the sites switch allocations and begin enrolling new participants under these allocations).
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| Up to 12 months after return of genetic test results |
| Patient-reported satisfaction, knowledge, and decision quality related to genetic testing | Patient-reported outcomes assessed using a study-specific survey administered after receipt of information about genetic testing and discussion with a heart specialist. The survey includes: Knowledge items assessed using true/false/"I don't know" questions related to inherited heart disease and genetic testing Attitudinal items assessing views on genetic testing using 5-point Likert scales, where higher scores indicate more favorable views Experience and process items assessed using yes/no questions (e.g., whether sufficient time was provided) Decision satisfaction and decision quality items assessed using 5-point Likert scales ranging from strongly disagree (1) to strongly agree (5), with higher scores indicating greater satisfaction and alignment with personal values | At 12 months after first participant enrollment |
| Proportion of participants with a change to family screening recommendations following genetic test results | Change in family screening recommendations is defined as any new, modified, or discontinued recommendation for screening of first- or second-degree relatives documented in the participant's medical record after return of genetic test results. This includes, but is not limited to:
| Up to 12 months after return of genetic test results |
| Calgary |
| Alberta |
| T2N2T9 |
| Canada |
| Vancouver General Hospital Cardiac Function Clinic | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital Heart Function Clinic | Vancouver | British Columbia | V6Z1Y6 | Canada |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |